(28 days)
Intended for use in radiographic fluoroscopic applications including cardiar, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
These CMOS X-ray detectors feature: The MX Imaging CMOS Flat Panel Detectors are designed for medical x-ray imaging applications. The CMOS panels are real-time x-ray detectors. The Detectors use a state of the art CMOS Imaging sensor that is based on a special pixel architecture enabling the detectors to be used in high sensitivity applications such as x-ray fluoroscopy/pulsed fluoroscopy, as well as applications requiring a large dynamic x-ray range such as radiography serial and radiography applications. The CMOS Flat Panel Detector is a component, and forms the part of a complete fluoroscopic x-ray system. The CMOS Detector interfaces to the Host X-Ray System through the associated interface connectors on the flat panel. The CMOS Flat Panel Detector is also synchronized to the X-Ray Generator via the interface cables. The intended use for this device is for Image Intensifier replacement in legacy surgical C-Arm systems.
The provided document is a 510(k) premarket notification for MX Imaging, Inc.'s CFP-3131 and CFP-2222 X-ray detectors. This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for novel devices. Therefore, the information provided focuses on non-clinical testing against established standards and comparison to a predicate device.
Here's an analysis based on your request, highlighting what is and isn't available in this specific document:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria (e.g., in terms of imaging performance metrics like DQE, MTF, SNR values) and corresponding reported device performance values. Instead, it states that "Non-clinical testing was performed successfully according to the following standards" and lists regulatory standards and guidance documents. This implies that the device met the requirements outlined within those standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI ES60601-1:2005 +C1:2009 +A2:2020 +A1:3012 (Medical Electrical Equipment: General Requirements for Basic Safety and Essential Performance) | Tested successfully to this standard. |
| Compliance with IEC 60601-1-2:2007 (Medical Electrical Equipment: Electromagnetic Disturbances Requirements and Tests) | Tested successfully to this standard. |
| Compliance with 21 CFR 1020.30, 1020.31, and 1020.32 (US FDA Radiation Safety Performance Standard) | Meets the applicable requirements. |
| Compliance with FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (Sept 1, 2016) | Non-clinical testing performed in accordance with this guidance. |
| Consideration of Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance (Oct 2014) | Internal SOPs updated, cybersecurity precautions added to software user manuals. |
| Consideration of FDA's pediatric guidance ("Pediatric Information for X-ray Imaging Device Premarket Notifications") | Utilized in the preparation of labeling documentation. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Non-clinical testing was performed..." and "6. Clinical testing. Not required for a determination of substantial equivalence."
Therefore, there was no "test set" of patient data in the sense of a clinical study. The testing involved adherence to engineering and safety standards for the device itself.
- Sample size for test set: Not applicable (no clinical test set).
- Data provenance: Not applicable (no clinical data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical test set was used, no ground truth needed to be established by experts for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an X-ray detector (hardware), not an AI-powered diagnostic tool. Therefore, an MRMC study assessing human reader performance with or without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this is for X-ray detector hardware, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of hardware submission, "ground truth" relates to the device meeting technical specifications and safety standards, rather than diagnostic accuracy against a clinical gold standard. The "ground truth" implicitly assumed is that the device, when combined with a compatible C-arm, produces diagnostic fluoroscopic X-ray images that are functionally equivalent to those produced by the predicate device and meet established safety and performance benchmarks.
8. The sample size for the training set
Not applicable. This device is hardware component (CMOS Flat Panel Detector), not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.